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Lack of recruitment.
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The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dotarem | Experimental | Each subject will receive one injection of Dotarem 0.2ml/kg. |
|
| Time Of Flight | Other | Each subject will undergo a TOF Magnetic Resonance Angiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dotarem | Drug | Each subject will receive one injection of Dotarem 0.2ml/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Non Assessable Renal Artery Segments | For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared | 1 to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre DESCHE, MD | Guerbet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guerbet LLC | Bloomington | Indiana | 47403 | United States |
Out of the 13 enrolled patients, three did not receive treatment, mainly due to the Sponsor decision to interrupt the study
The recruitment started in Sept 2009 and stopped in February 2010. Radiology departments from hospital or private practices were participating.
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| ID | Title | Description |
|---|---|---|
| FG000 | TOF Followed by Dotarem-enhanced MRA | Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TOF MRA |
| |||||||||||||
| Dotarem MRA |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TOF Followed by Dotarem-enhanced MRA | Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Non Assessable Renal Artery Segments | For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared | Posted | Number | percentage of non-assessable segments | 1 to 7 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dotarem | Each subject will receive one injection of Dotarem 0.2ml/kg. Dotarem: Each subject will receive one injection of Dotarem 0.2ml/kg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders |
The study was not completed due to poor enrolment. The statistical analysis was not perfomed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pierre Desche, MD, Head of Clinical and Regulatory Affairs | Guerbet | +33 1 45 91 50 00 | pierre.desche@guerbet-group.com |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C072417 | gadoterate meglumine |
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| Time of Flight | Other | Each subject will undergo a TOF MRA |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Counts |
|---|
| Participants |
|
|
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Time Of Flight | Each subject will undergo a TOF Magnetic Resonance Angiography Time of Flight: Each subject will undergo a TOF MRA | 0 | 10 | 0 | 10 |
| Injection site inflammation | General disorders |
|
| Abdominal pain | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
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| D052801 | Male Urogenital Diseases |